The report of an initiative undertaken jointly by the European Medicines Agency (EMA) and the European network for Health Technology Assessment(EUnetHTA) to make regulators’ reports about scientific assessments of medicines more usable by health technology assessment (HTA) bodies, has been published in Value in Health, the Journal of The International Society For Pharmacoeconomics And Outcomes Research.
The article, entitled, "Improving the Contribution of Regulatory Assessment Reports to Health Technology Assessments–a Collaboration between the European Medicines Agency and the European Network for Health Technology Assessment," is authored by staff members of the EMA and representatives of EUnetHTA. This work was the first joint project between regulators and HTA bodies on a European level and is part of their ongoing dialogue to support policy-maker decisions in the future.
Clinical data generated by pharmaceutical companies during the development process of a medicine is the basis for the evaluation of the benefit/risk balance of a medicine for the purpose of marketing authorization. The same data inform the assessment of the effectiveness of the new medicines compared to existing therapies, as part of the HTA process to support decision making on appropriate utilization, price, and reimbursement in the member states of the European Union (EU).
The joint EMA-EUnetHTA project responded to a political recommendation to consider how the assessment of the favorable and unfavorable effects of a medicine as contained in the EMA’s European Public Assessment Reports (EPARs) can best be used to inform the assessment of the relative effectiveness of new medicines for HTA purposes in EU member states. As part of this project, the EMA and EUnetHTA developed an improved structure and presentation of key information with the view to increase clarity and transparency of the outcome of the scientific-review process as reflected in the EPARs.
Beyond the EPARs project, the EMA and EUnetHTA are continuing to explore other areas of collaboration or exchange of information. These include ways for sponsors to obtain scientific advice or early dialogues with regulators and HTA or payer bodies, discussions and exchange on scientific and methodological guidelines, exploring opportunities of exchange on regulatory assessments in view of subsequent health technology assessments, post-licensing data generation, and the specificities of orphan medicinal products. Regular meetings are held between EMA and EUnetHTA, most recently on May 15, 2014. Minutes from these meetings are made available on the websites of both the EMA and EUnetHTA, as is the joint three-year work plan.